Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia (DABI-SNAP)

Emily McDonald

Status and phase: Not yet enrolling; Phase 4

Conditions: S. Aureus Bacteremia; Staphylococcus Aureus Septicemia; Staphylococcus Aureus Endocarditis; S. Aureus Bloodstream Infection; Staphylococcus Aureus Bloodstream Infection; Staphylococcus Aureus Bacteremia

Treatments: Drug: Dabigatran; Drug: Rivaroxaban; Drug: Apixaban; Drug: edoxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT06650501

2025-10900

500464 (Other Grant/Funding Number)

Details and patient eligibility

About

This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication.

Dabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigratran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it.

This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119).

If positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:

Inclusion Criteria:

• Patient is taking an oral Xa inhibitor for: stroke prevention in atrial fibrillation, treatment or secondary prevention of deep venous thrombosis or pulmonary embolism, prevention of VTE in patients who have undergone elective total hip or total knee replacement surgery provided there are 30 or more days of planned treatment remaining at the time of enrolment.

Exclusion Criteria:

• Active bleeding (allowing up to 5 days from the index blood culture to randomize in the event anti-thrombotic therapy is resumed)
• Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days
• Pregnancy
• Known use of dabigatran within last month
• Allergy to dabigatran
• Concomitant use of amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor
• eGFR < 30mL/minute calculated by Cockcroft-Gault equation using adjusted weight [if acute kidney injury can allow for up to 5 days from index blood culture to allow for recovery]
• Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Change to Dabigatran

Experimental group

Description:

Patients will have their anticoagulation changed to dabigatran at the monograph approved dose for the indication, bleeding risk, and renal function.

Treatment:

Drug: Dabigatran

Continue current anticoagulant

Active Comparator group

Description:

Patients will continue their currently prescribed apixaban, edoxaban, or rivaroxaban

Treatment:

Drug: edoxaban

Drug: Apixaban

Drug: Rivaroxaban